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立法院三讀通過「再生醫療法」開啟再生醫療新里程

        再生醫療法由朝野黨團、公私團體及行政部門歷經多年來的共同努力，於113年6月4日由立法院完成三讀。對於尚缺乏治療方法，或現有治療方式效果不佳之急重症病人，除了參與人體臨床試驗之外，先進國家莫不積極尋求解決之道，著重於應用醫療創新以增加拯救生命的機會。

        為呼應此一未被滿足的醫療需求，衛生福利部自107年起著手「再生醫療法」籌備工作，今終於完成立法，是確保醫療機構執行再生醫療之安全及品質、維護病人接受治療之權益的重大里程碑。

        再生醫療法的通過，除促進再生醫療領域發展，亦加速再生醫療研發成果擴大應用至臨床醫學。全文共計35條七章節，重點如下：

一、研究發展促進：為確保提供病人安全有效之治療，醫療機構執行再生醫療前應進行並完成人體試驗，以促進再生醫療研究發展，予以獎勵或補助。

二、再生技術管理：明定醫療機構執行再生醫療之範疇、執行醫師之資格及應向病人充分說明相關權利義務等事項，以確保再生醫療之安全、品質及有效性。

三、細胞源頭管理：細胞操作執行機構及細胞保存庫，應對組織、細胞提供者進行合適性判定。

四、加重罰則：因再生醫療之執行影響病人生命、身體或健康甚鉅，除加重對非醫療機構執行再生醫療或為再生醫療廣告之處罰至最高2千萬元外，非醫療機構執行再生醫療，得沒入其執行再生醫療之設備及再生製劑。

衛生福利部再次感謝朝野立委及民間團體之協助與溝通，透過本次立法呼應再生醫療之臨床實務管理需求及產業發展需求，對確保再生醫療安全、品質及有效性，維護病人權益，至為關鍵。

The Legislative Yuan passed the

"Regenerative Medicine Act" in the third reading,

opening a new milestone in regenerative medicine

   The Regenerative Medicine Act was passed by the Legislative Yuan on June 4, 2014, after years of joint efforts by ruling and opposition parties, public and private groups, and the executive branch. For critically ill patients who lack treatments or for whom existing treatments are ineffective, in addition to participating in human clinical trials, advanced countries are actively seeking solutions and focusing on applying medical innovations to increase the chances of saving lives.

    In order to respond to this unmet medical need, the Ministry of Health and Welfare has started preparatory work for the "Regenerative Medicine Act" since 2017. The legislation has finally been completed. This is a major milestone in ensuring the safety and quality of regenerative medicine performed by medical institutions and safeguarding the rights and interests of patients receiving treatment.

    The passage of the Regenerative Medicine Act not only promotes the development of the regenerative medicine field, but also accelerates the application of regenerative medicine research and development results to clinical medicine. The full text consists of 35 articles and seven chapters, the key points are as follows:

1. Promotion of research and development: To ensure that patients are provided with safe and effective treatment, medical institutions should conduct and complete human trials before implementing regenerative medicine, so as to promote the development of regenerative medicine research and provide incentives or subsidies.

2. Regenerative technology management: Specify the scope of regenerative medicine performed by medical institutions, the qualifications of physicians who perform the treatment, and the need to fully explain relevant rights and obligations to patients, so as to ensure the safety, quality, and effectiveness of regenerative medicine.

3. Cell source management: Cell operation execution agencies and cell storage banks should make suitability assessments on tissue and cell providers.

4. Increased penalties: Because the implementation of regenerative medicine has a significant impact on the life, body or health of patients, in addition to increasing the penalty for non-medical institutions that implement regenerative medicine or advertise regenerative medicine to a maximum of NT$20 million, non-medical institutions that implement regenerative medicine may have their regenerative medicine equipment and regenerative preparations confiscated.

    The Ministry of Health and Welfare once again thanks the ruling and opposition legislators and non-governmental organizations for their assistance and communication. Through this legislation, we will respond to the clinical practice management needs and industry development needs of regenerative medicine, which is crucial to ensuring the safety, quality and effectiveness of regenerative medicine and safeguarding the rights of patients.

新醫療技術人體試驗案審查作業

        依據人體試驗管理辦法第2、3條所提，醫療機構將新醫療技術列入常規醫療處置項目前，應施行人體試驗研究，向中央主管機關申請核准。遂衛生福利部依據醫療法第78條及79條規定受理新醫療技術人體試驗案審查作業，惟為加速新醫療技術案審查作業，衛生福利部自110年6月起委託醫策會協助研擬「新醫療技術人體試驗案-審查標準作業程序」，以利申請者及人體研究倫理審查委員會依循，及執行新醫療技術人體試驗案審查作業，並持續檢討改善相關作業流程，以保障受試者及研究對象權益與安全。

        為提高國內醫療技術水準及預防疾病上之需要，衛生福利部公告「新醫療技術人體試驗案－審查標準作業程序」，並委託財團法人醫院評鑑暨醫療品質策進會辦理案件審查相關行政事務。

  一、受理範圍：

         (一) 新醫療技術人體試驗案之案件屬性判定。

         (二) 新醫療技術人體試驗案之審查作業。

  二、 流程圖：

         (一) 新醫療技術人體試驗案之屬性判定作業流程圖

            流程如檔案附件：

https://drive.google.com/file/d/1DI60qY_R92ngsq5PluVQ19zxB9Numljs/view

Review of new medical technology human trials

      According to Articles 2 and 3 of the Measures for the Management of Human Experiments, before medical institutions include new medical technologies in routine medical treatment items, they should conduct human experiment research and apply to the central competent authority for approval. Therefore, the Ministry of Health and Welfare accepts the review of new medical technology human trials in accordance with Articles 78 and 79 of the Medical Act. However, in order to speed up the review of new medical technology cases, the Ministry of Health and Welfare has entrusted the Medical Policy Council to assist in the development of "New Medical Technology Human Trials - Review Standard Operating Procedures" in June 2010 to facilitate applicants and the Human Research Ethics Review Committee to follow and carry out the review of new medical technology human trials, and continue to review and improve relevant operating procedures to protect the rights and safety of subjects and research subjects.

      In order to improve the level of domestic medical technology and prevent diseases, the Ministry of Health and Welfare announced the "New Medical Technology Human Trial Case - Review Standard Operating Procedures" and entrusted the Hospital Evaluation and Medical Quality Promotion Foundation to handle administrative affairs related to case review.

  1. Scope of Acceptance:

      (1) Determination of the nature of cases involving human trials of new medical technologies.

      (2) Review of new medical technology human trial cases.

  2. Flowchart:

      (I) Flowchart of the attribute determination process for new medical technology human trials

The process is as attached：

https://drive.google.com/file/d/1DI60qY_R92ngsq5PluVQ19zxB9Numljs/view